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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K142600
Device Name VIAL-MATE Adaptor
Applicant
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD,
ROUND LAKE,  IL  60073
Applicant Contact GARY CHUMBIMUNE
Correspondent
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD,
ROUND LAKE,  IL  60073
Correspondent Contact GARY CHUMBIMUNE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received09/15/2014
Decision Date 11/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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